Healthy VolunteersPhase 1NCT02063386
AZD1722 Open Label, Absorption Distribution Metabolism and Excretion Study
A Phase 1 study testing AZD1722 in people with Healthy Volunteers, run by Ardelyx at 1 site in United Kingdom.
Trial summary
To assess the absorption, distribution, metabolism and excretion of a single dose of 14C labelled AZD1722 in order to define the rates and routes of elimination of AZD1722 and if formed, metabolites. Read more about this study
- Who is it for?
- Ages 50 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- AZD1722
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2014to May 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male volunteers aged ≥50 years
- Regular daily bowel movements.
- Have a body mass index (BMI) between 18 and 32 kg/m2 (inclusive) and weigh at least 50 kg and no more than 110 kg.
Who cannot join
- History of any clinically significant disease or disorder which, in the opinion of the Principal Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study.
- History or presence of GI, hepatic or renal disease including GI surgery other than appendectomy or any other condition known to interfere with the ADME of drugs.
- Loose stools (Bristol Stool Form Score of 6 or 7) ≥2 days in the past 7 days before admission to the study centre
- Use of medications that are known to affect stool consistency and/or GI motility, including fibre supplements, anti-diarrheals, prokinetic drugs, enemas, probiotic medications or supplements; or salt or electrolyte supplements containing sodium, potassium, chloride, or bicarbonate formulations during the past 7 days before admission to the study centre.
- Volunteers exposed to radiation levels above background (eg, via X-ray examination) of >5 mSv in the last year, >10 mSv over the last 5 years or a cumulative total of >1 mSv per year of life.
- Participation in a previously radiolabelled study within the last 5 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Single-centre, Open-label Study to Assess the Absorption, Distribution, Metabolism and Excretion (ADME) of a Single Oral Dose of 14C-labelled AZD1722 in Healthy Male Volunteers
To assess the absorption, distribution, metabolism and excretion of a single dose of 14C labelled AZD1722 in order to define the rates and routes of elimination of AZD1722 and if formed, metabolites.
- Conditions
- Healthy Volunteers
- Being tested
- AZD1722
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD1722Drug
Single oral dose 15 mg of [14C]AZD1722
| Study group | Role | What they receive |
|---|---|---|
| AZD1722 | Experimental | Single oral dose 15 mg of [14C]AZD1722 Receives: Drug: AZD1722 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of radioactive dose recovered in urine and feces
Measured: Day 1: Pre-dose and up to 168 hours post-dose
Total percentage of radioactive dose recovered from both urine and feces
Measured: Day 1: Pre-dose and up to 168 hours post-dose
Concentration of total radioactivity in blood and plasma samples
Measured: Timeframe: Day 1: Predose and up to 120 hours
Concentration of AZD1722 in plasma samples
Measured: Timeframe: Day 1: Predose and up to 120 hours
Secondary outcomes (1)
Safety variables (adverse events, vital signs, ECGs, clinical laboratory tests)
Measured: up to 50 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2014 (estimated)
- Study startApr 2014
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ardelyx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02063386
- Sponsor's protocol ID
- D5611C00007
- Status last verified
- Sep 2015
- First submitted
- 13 Feb 2014
- Last updated
- 22 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-centre, Open-label Study to Assess the Absorption, Distribution, Metabolism and Excretion (ADME) of a Single Oral Dose of 14C-labelled AZD1722 in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02063386
- Acronym / sponsor ID
- D5611C00007
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- ArdelyxIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 14 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the absorption, distribution, metabolism and excretion of a single dose of 14C labelled AZD1722 in order to define the rates and routes of elimination of AZD1722 and if formed, metabolites.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AZD1722 | Experimental | Drug: AZD1722Single oral dose 15 mg of [14C]AZD1722 |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy male volunteers aged ≥50 years
- Regular daily bowel movements.
- Have a body mass index (BMI) between 18 and 32 kg/m2 (inclusive) and weigh at least 50 kg and no more than 110 kg.
Key exclusion criteria (6 listed)
- History of any clinically significant disease or disorder which, in the opinion of the Principal Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study.
- History or presence of GI, hepatic or renal disease including GI surgery other than appendectomy or any other condition known to interfere with the ADME of drugs.
- Loose stools (Bristol Stool Form Score of 6 or 7) ≥2 days in the past 7 days before admission to the study centre
- Use of medications that are known to affect stool consistency and/or GI motility, including fibre supplements, anti-diarrheals, prokinetic drugs, enemas, probiotic medications or supplements; or salt or electrolyte supplements containing sodium, potassium, chloride, or bicarbonate formulations during the past 7 days before admission to the study centre.
- Volunteers exposed to radiation levels above background (eg, via X-ray examination) of >5 mSv in the last year, >10 mSv over the last 5 years or a cumulative total of >1 mSv per year of life.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD1722Single oral dose 15 mg of [14C]AZD1722 | Drug | AZD1722 |
Primary outcome
Percentage of radioactive dose recovered in urine and feces
Time frame: Day 1: Pre-dose and up to 168 hours post-dose
Total percentage of radioactive dose recovered from both urine and feces
Time frame: Day 1: Pre-dose and up to 168 hours post-dose
Concentration of total radioactivity in blood and plasma samples
Time frame: Timeframe: Day 1: Predose and up to 120 hours
Concentration of AZD1722 in plasma samples
Time frame: Timeframe: Day 1: Predose and up to 120 hours
1 secondary outcome
Safety variables (adverse events, vital signs, ECGs, clinical laboratory tests)
Time frame: up to 50 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2015.
- CSR SynopsisLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD1722 in people with Healthy Volunteers, run by Ardelyx at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of radioactive dose recovered in urine and feces (time frame: Day 1: Pre-dose and up to 168 hours post-dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2015.